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Collection and Storage of Umbilical Cord Stem Cells for Treatment of Sickle Cell Disease Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Collection and Storage of Umbilical Cord Stem Cells for Treatment of Sickle Cell Disease conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Collection and Storage of Umbilical Cord Stem Cells for Treatment of Sickle Cell Disease Clinical research trials and Collection and Storage of Umbilical Cord Stem Cells for Treatment of Sickle Cell Disease health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Collection and Storage of Umbilical Cord Stem Cells for Treatment of Sickle Cell Disease. Collection and Storage of Umbilical Cord Stem Cells for Treatment of Sickle Cell Disease Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Collection and Storage of Umbilical Cord Stem Cells for Treatment of Sickle Cell Disease clinical trial. Human subjects often get the best healthcare possible for their Collection and Storage of Umbilical Cord Stem Cells for Treatment of Sickle Cell Disease condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Collection and Storage of Umbilical Cord Stem Cells for Treatment of Sickle Cell Disease  Collection and Storage of Umbilical Cord Stem Cells for Treatment of Sickle Cell Disease
Collection and Storage of Umbilical Cord Stem Cells for Treatment of Sickle Cell Disease
For Condition: Healthy,Sickle Cell Anemia
Status: Recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: This study will determine the best ways to collect, process and store umbilical cord blood from babies with sickle cell disease, sickle cell trait and unaffected babies. Sickle cell disease is an abnormality of the hemoglobin in red blood cells that causes the cells to change shape and clump together, preventing their normal flow in the bloodstream. This impairs blood flow to various organs, and the resulting oxygen deprivation causes organ damage. Cord blood is rich in stem cells (cells produced in the bone marrow that mature to different types of blood cells), which may prove useful in new sickle cell therapies. However, cord blood from babies with sickle cell trait, sickle cell disease and normal babies may act differently under laboratory conditions, so it is important to learn how best to work with blood from all three groups of babies for future use in possible treatments. Pregnant women between 18 and 45 years of age who are at risk of having an infant with sickle cell disease and normal volunteers who are pregnant and not at risk for this disease may be eligible for this study. Potential participants will be counseled about donating her infant's blood in order to make an informed choice. All women who participate in the study will provide a medical history and have blood collected from the umbilical cord and placenta (afterbirth) after the baby's delivery. The blood will be tested for various infectious diseases, processed, frozen and stored for research purposes. In addition, blood from women with babies at risk for sickle cell disease will be tested for the presence of the sickle cell gene, tissue typed, and used for research as follows: - Sickle cell disease - If cord blood tests show the baby has sickle cell disease, the blood will be frozen for an indefinite period of time for possible use in future treatment of the child. This treatment could include stem cell transplantation or gene therapy, treatments are not currently considered routine for sickle cell disease. - Sickle cell trait or normal hemoglobin - If cord blood tests show the baby has sickle cell trait or is unaffected, the blood will be processed and stored for up to 3 years, during which time it may possibly be used to treat a currently living or future sibling with sickle cell disease. After 3 years, the participant may agree to either have the blood discarded, given to research or moved to another facility for continued storage at the participant's expense, if there is a storage fee. Alternatively, if there is no anticipated future need for the collected blood, or if it does not meet standards needed for future treatment, it will be used in NIH-approved research studies. Participants and their family doctor or the baby's pediatrician will be contacted twice a year for information about changes in the baby's health. Participants may also be asked permission to perform new tests developed by researchers.
Details: Umbilical cord blood is a source of hematopoietic stem cells (HSCs) for transplantation or gene therapy. Our goal is to procure umbilical cord blood (UCB) from newborns at risk for sickle cell disease, sickle cell trait, and related disorders as well as normal newborns, for our controls, in order to develop methods for processing and cryopreservation of umbilical cord blood HSCs for use in future clinical transplantation or gene therapy. In order to carry out our methods development research umbilical cord blood units will be collected from an indefinite number of subjects until 30 cord blood units from newborns with sickle cell disease have been cryopreserved. These units will be stored for future gene therapy. Maternal subjects will have been identified as being at risk to have an infant with sickle cell disease, will be between the ages of 18 and 45, will meet specified medical history criteria. The cord blood units will be tested for transfusion transmissible viruses, infectious disease markers, Human Leukocyte Antigen (HLA) typing, Hemoglobin genotyping, and enumeration of progenitor cells. The umbilical cord blood units will be used for the developmental research on processing/cryopreservation methods but, once processed and stored, may also be identified for future clinical use or for basic or translational research by NIH investigators. This study will be a multisite collaboration with Washington metropolitan area hospitals.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: INCLUSION CRITERIA: Pregnant women who are at risk of having an infant with sickle cell anemia (HbSS), as well as woman who are not at risk and wish to serve as control subjects, will be identified and referred by their health care providers or will be self-referred. Maternal subjects must be between 18 and 45 years old, may be in their first or subsequent pregnancy, and must be able to provide informed consent. EXCLUSION CRITERIA: The maternal subject will not be eligible for study if she is known to be positive for one or more of the following diseases transmissible by blood: HIV, hepatitis C, or HTLV; is unable to give informed consent; or is known to have a fetus with a significant congenital anomaly. Subjects may be excluded at the time of delivery if the attending physician or collection staff, due to unanticipated obstetrical complications, deems cord blood collection inadvisable.
Total Enrollment: 9999999
Location and Contact Information:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 010122; 01-DK-0122
Study Start Date: March 8, 2001
Record last reviewed: February 25, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012545
Other Sickle Cell Anemia Studies:
1. Evaluation of Hydroxyurea Plus L-arginine or Sildenafil to Treat Sickle Cell Anemia
2. Effects of Nitric Oxide and Nitroglycerin in Patients with Sickle Cell Anemia
3. Bone marrow transplant from donor using less toxic conditioning for patient with high risk hemoglobinopathies
4. Inhaled Nitric Oxide and Transfusion Therapy for Patients with Sickle Cell Anemia and Secondary Pulmonary Hypertension
5. Decompression Coring Versus Conservative Therapy in Patients With Avascular Necrosis of the Hip Related to Sickle Cell Disease
Related Studies:
Other Sickle Cell Anemia Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Collection and Storage of Umbilical Cord Stem Cells for Treatment of Sickle Cell Disease
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